Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension

This study has been completed.

Sponsor:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT01316419

First Posted: March 16, 2011

Last Update Posted: September 21, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

This is an observational study to evaluate the effects of Twynsta tablets (Telmisartan and amlodipine fixed dose combination (FDC), once daily (q.d.)) with life style modifications on blood pressure, quality of life, and other risk factors in Korean patients with hypertension

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Twynsta (Telmisartan and Amlodipine FDC) Tablets

Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All treated patients fulfilling the inclusion-exclusion criterias and who have completed the follow-up visits of the study.

Reporting Groups

Description

Twynsta (Telmisartan and Amlodipine FDC) Tablets

Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.